- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05196425
Expression of PARP-1 in Multiple Sclerosis Patients
Expression of PARP-1 in Optic Neuritis of Multiple Sclerosis Patients
This study will explore the expression of PARP-1 in optic neuritis of multiple sclerosis patients.
The data will be collected from Sohag University hospital in the period from the start of August 2021 to the end of December 2021.
The study protocol will be approved by the Scientific Research Ethical Committee, Faculty of Medicine, Sohag University.
Study Overview
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Sohag, Egypt, 82511
- Elshimaa A.Mateen
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Patients with multiple sclerosis with or without optic neuritis Multiple sclerosis will be diagnosed according to the McDonald criteria
Exclusion Criteria:
- • Isolated optic neuritis.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Control group
|
Blood sample for detection of PARP-1 gene and correlate to changes of the optic disc, RNFL and GCC layers of the retina of MS patients
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Active Comparator: MS with optic neuritis
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Blood sample for detection of PARP-1 gene and correlate to changes of the optic disc, RNFL and GCC layers of the retina of MS patients
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Active Comparator: Ms without optic neuritis
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Blood sample for detection of PARP-1 gene and correlate to changes of the optic disc, RNFL and GCC layers of the retina of MS patients
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
measure PARP-1 mRNA
Time Frame: 2 weeks
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measure PARP-1 mRNA
|
2 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Optic nerve, RNFL and GCC layer affection by MS
Time Frame: 2 weeks
|
Optic nerve Retinal nerve fibre layer (RNFL) in um ) and Ganglion cell complex (GCC) layer affection in um by MS in correlation to PARP-1 mRNA |
2 weeks
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Soh-Med-21-05-12
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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